Method and device for analysing a liquid

• US 7,437,913 B2
• Filed: 11/25/2003
• Issued: 10/21/2008
• Est. Priority Date: 06/06/2003
• Status: Expired due to Term

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated), Hall Effect Technologies, Ltd.
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Djennati, Nasr-Eddine, Fuller, Jonathan Andrew, Scott, David, Porter, Robert Andrew
• Primary Examiner(s): Williams; Hezron E.
• Assistant Examiner(s): West; Paul M
• Application Number:
  US10/722,106
• Publication Number:
  US 20050015000A1
• Time in Patent Office: 1,792 Days
• Field of Search: 73/616.6, 324/204, 324/207.21
• US Class Current: 73/64.41
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54

Abstract

Novel methods and devices comprising magnetic particles for detecting or monitoring the coagulation state of a sample are provided.

Claims

1. A device for determining the coagulation state of a sample comprising:

a sample chamber defining a volume for receiving a sample to be analysed, the sample chamber having a sample chamber major axis;

at least one particle disposed within the chamber volume wherein the at least one particle comprises at least one material which experiences a force when placed in a magnetic field;

a first electromagnet and a second electromagnet for applying a magnetic field to at least part of the chamber volume, the first electromagnet being spaced apart from the second electromagnet by the sample chamber, the first electromagnet having a first electromagnet major axis, the second electromagnet having a second electromagnet major axis, and the first electromagnet major axis and the second electromagnet major axis being parallel to the sample chamber major axis;

at least one sensor operative to detect a response, along the sample chamber major axis, of the at least one particle to the magnetic field; and

a processor configured to determine the coagulation state of the sample based on the response, along the sample chamber major axis, of the at least one particle to the magnetic field.

2. The device of claim 1, wherein said device further comprises a display.

3. The device of claim 1, wherein said device displays a value that is correlated with a disturbance of hemostasis.

4. The device of claim 1, wherein said device displays a clotting time and/or an INR value.

5. The device of claim 1, wherein said sample may be blood or plasma.

6. The device of claim 1, further comprising a filling chamber.

7. The device of claim 6, further comprising a filling device for filling the chamber.

8. The device of claim 7, where said filling device comprises a capillary.

9. The device of claim 1, wherein said material which experiences a force when placed in a magnetic field may be ferromagnetic, paramagnetic, or superparamagnetic.

10. The device of claim 1, where the at least one particle is generally spherical.

11. The device of claim 1, where the at least one particle has a size in the range of about 2 to about 500 μ

m.

12. The device of claim 11, wherein the at least one particle has a size in the range of about 2 to about 20 μ

m in at least one direction.

13. The device of claim 1, wherein the at least one particle comprises two or more different materials and wherein at least one material experiences a force when exposed to a magnetic field.

14. The device of claim 1, wherein more than one particle is disposed in said volume.

15. The device of claim 1, wherein said magnetic field is between about 1 and about 100 mT.

16. The device of claim 15, wherein said magnetic field is between about 10 and about 50 mT.

17. The device of claim 16, wherein the magnetic field is between about 10 to about 20 mT.

18. The device of claim 1, wherein the device further comprises at least one reagent disposed within a chamber prior to introduction of a sample into the device.

19. The device of claim 18, wherein the reagent is selected from the group consisting of:

clotting agents, anti-clotting agents, and reagents suitable for measurement of a disturbance of hemostasis.

20. The device of claim 1, wherein each electromagnet produces a constant field and is activated alternately with a direct current.

21. The device of claim 1, wherein the sensor is a Hall Effect sensor.

22. The device of claim 1, wherein the device further comprises circuitry for measuring the time elapsed from introduction of a sample until a change in coagulation state is detected.

23. The device of claim 1, wherein the device further comprises a control means.

24. The device of claim 1, wherein the chamber has a volume of less than about 25 μ

l.

25. The device of claim 24, wherein the chamber has a volume less than about 5 μ

l.

26. The device of claim 1, wherein the device further comprises a means for heating the chamber.

27. The device of claim 1, wherein the chamber is formed in a disposable support strip which is removable from the device.

28. The device of claim 1, wherein the ratio of the chamber volume to the particle volume is about 30 or greater.

29. A method of determining the coagulation state of a sample comprising:

providing a sample in a sample chamber, the sample chamber having a major axis, and the sample containing at least one particle comprising a material which experiences a force when placed in a magnetic field;

applying a magnetic field to said sample using a first electromagnet and a second electromagnet, the first electromagnet being spaced apart from the second electromagnet by the sample chamber, the first electromagnet having a first electromagnet major axis, the second electromagnet having a second electromagnet major axis, and the first electromagnet major axis and the second electromagnet major axis being parallel to the sample chamber major axis; and

using a sensor to detect a response, along the sample chamber major axis, of the at least one particle to the magnetic field to determine the coagulation state of the sample.